FOSTER CITY, Calif., March 14, 2023 /PRNewswire/ — TrueBinding, Inc.— a clinical-stage biotherapeutic company creating new and exciting molecules for applications in neurodegenerative and other disease areas with great unmet needs— announced today that the company has been granted a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food & Drug Administration (FDA). The meeting will occur in April 2023 and promote discussion of a rapid development pathway for TrueBinding’s TB006— a novel antibody for treating Alzheimer’s Disease— and allow the company to receive guidance from the FDA on successfully expediting its programs.
“TB006 is an antibody for the treatment of Alzheimer’s Disease, a difficult-to-treat disease with critical unmet need,” said Dr. Dongxu Sun, Ph.D., Chief Executive Officer of TrueBinding and an expert in the development of novel drugs. “We are grateful for the FDA’s continued support and guidance for the development of therapeutics and biologics for diseases that are difficult to treat, and we look forward to getting their feedback and guidance on our Alzheimer’s Disease study.”
TrueBinding previously received FDA clearance for its investigational new drug application (IND) for the use of TB006 in human clinical trials for the treatment of Alzheimer’s Disease in April 2021. TB006 is currently being evaluated in a Phase 2 Open Label Extension (OLE) trial, a decision made after the blinded trial was complete and the treatment was deemed to have potential benefits for patients living with Alzheimer’s Disease. The company has completed phase 2a trials and will soon commence phase 2b.
During the upcoming Type B EOP2 meeting, TrueBinding will discuss the results and status of both clinical and non-clinical programs, and the drug’s readiness for the Biologics License Application (BLA) approval process, which once achieved will allow TB006 to be prepared for market and patient availability.
“The outcome of this meeting will strengthen the upcoming clinical trial phases for our Alzheimer’s Disease study with TB006,” said Dr. Sun. “Everything we learn and discuss will be used to help TB006 get closer to doing exactly what we’re developing it to do: help those with Alzheimer’s Disease to fill a fuller, better life.”
TB006 is a humanized monoclonal antibody that, by blocking Galectin-3, the root cause of neuroinflammation and aggregation of Aβ and pTau and other pathogenic factors, has the potential to improve cognition and functioning of patients with Alzheimer’s disease (AD). In AD in vivo model studies, TB006 showed promising capabilities in significant reduction of the aggregation of Aβ/Tau proteins and neuroinflammation, and significant improvement of cognitive performance. In a Phase 1b/2a proof-of-concept trial in mild to severe AD patients, TB006 demonstrated great improvements in cognition and functioning. TB006 is currently being evaluated in a Phase 2 open-label extension trial in patients with AD and in a Phase 2 trial in patients with acute ischemic stroke.
About TrueBinding, Inc.
TrueBinding Inc. is a clinical-stage biotherapeutics company focused on pioneering the development of innovative monoclonal antibodies for the treatment of some of the most challenging neurodegenerative diseases, including Alzheimer’s disease (AD), as well as stroke, oncology and other serious diseases. For more information, visit www.truebinding.com.
SOURCE TrueBinding Inc.